Deanna Harshbarger, Cala Health - Reducing Essential Tremors | LSI USA '24

Deanna Harshbarger  0:03  
Hi, I'm Deanna    Harshbarger. And I'm going to tell you why. Calla is the only company that is producing a new therapy to transform the standard of care for tremor. And the reason is because there is a huge unmet need of patients with tremor who need better treatment options. And that number keeps growing year over year. Calla therapy has actually shown significant reduction in tremor, significant meaningful tremor reduction in clinical studies, and almost 2000 patients. And because we've been selling into the VA, we have proven that there is a high demand from patients and from neurologists that are prescribing. And also that it fits easily into the neurology workflow. And last, but not least, most importantly, is that Medicare will now be covering calla therapy for patients with essential tremor. And because of that, that is why calla is creating a market a $10 billion market for hand tremor that can increase by 2 billion annually. Because this is a significant number of patients seven to 10 million in the United States alone for essential tremor, 1 million with Parkinson's disease, and very few that get good treatment options with pharmacotherapy, and with invasive treatments. And the majority of these patients are over 65, almost 70%. So essential tremor is a neurodegenerative disease. And what that means is the tremor gets worse and worse over time. And that makes it really difficult for patients to do things that are very, very simple that we take for granted. Like being able to pick up a cup and drink, being able to use a fork to actually stab the food to bring it to your mouth, and being able to put your arm through through your actual sleep to get dressed. And so there is a strong critical need, but they're not great options. And what we're really excited about is that the international essential tremor Foundation has recommended calla as a therapy option for these patients with this treatment gap, the majority of patients will get diagnosed and start off on pharmacotherapy. pharmacotherapy, these drugs are not actually indicated for essential tremor. They're beta blockers. And so there are significant side effects that come with that. And as the disease gets worse and worse over time, they start to go up in their dosage. And that causes larger side effects. So it leaves this whole gap of patients that either may choose to go on to invasive surgical options, which is a very, very small amount. And all of these people that have no place to go. So meet Kela kick. I'm wearing it right here. It's very simple. And it is clinically validated, and it provides meaningful tremor relief. This was launched mid last year. And the reason that we launched this was twofold. One is to scale. So we ensure that we can get economies of scale because we know that there is this huge treatment gap. And that we need to be able to fill that and we need to be able to grow. So it's going to give us a great cogs. The other piece is to advance our IP portfolio. There's a lot of proprietary technology within the callate kick that we will be utilizing. And that will help us in the long term. The other unique aspect of the calla kick system is that the data from the patient is then put into the cloud. And the patient can look at their own data, see how they are doing and their tremor reduction and their usage, share that with their physician and also be able to take that to their doctor when they go in and talk about their treatment path. Carl is then able to look at that data and work on personalized treatment for the patient as well as population statistics. So how does it actually work? each patient's tremor is unique. And so what calla therapy does is it senses and gets the unique tremor from the individual patient utilizes that information to set the stimulation parameters. And what the stimulation does is it targets the ventral intermediate nucleus of the thalamus, which is the same target and deep brain stimulation for a central tremor. Does that peripheral Early through the median and the radial nerves, and then it is able to counteract the tremor. So calla therapy has been validated in almost 2000 patients, we have a significant amount of studies that have been published in peer reviewed journals. We have randomized clinical trials that show significant reduction in tremor, you can see a reduction in the activities of daily living, which is the things I was talking about before which are so important to the patients and in the standard of evaluation of tremor patients in Tetris. So that is done in large clinical studies to evaluate tremor. These are significant reductions in tremor. So not only do we show that on the short term, but we also show that in the long term with longitudinal studies, and you can see here that more than 90% of patients respond to calla therapy. And on average, they get an hour and a half of tremor reduction. Post stimulation. So this is one of our patients. This is Bob, you can read his quote, I think one of the great things from here is that he's talking about very critical aspects of his life that are needed, he's able to eat unaided, and excitingly, he's actually able to text his patients. So what has been our pathway? So calla was founded in 2015. And it got the clearance in 2018. And then our path has really been focused on driving towards reimbursement. We got national coverage with the VA in 2020. So we've been selling into the VA since 2020. And then in 2021, and 2022, we were able to get our payment determination, novel hickspicks codes, and most recently, we were able to get our positive local coverage determination from Medicare. And that will start our commercialization round. And so our team has over 100 years of experience working in medical devices, and in particular, almost 50 years working within movement disorders. And you can see a list of our major investors there. So, our recent Medicare coverage, our proven demand, and the fact that we are built to scale will move us into a full commercialization stage, we now have full access into the US market and we have unique codes. So this is an exciting time. This is a transforming option for patients and also for physicians. And if you are interested in learning more about kalah and our commercialization round, you can contact me this is all the usuals when you have a commercial product Thank you